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The Atellica™ CH Creatinine 2 (Crea 2) assay is for in vitro diagnostic use in the quantitative determination of creatinine in human serum, plasma (lithium heparin), and urine using the Atellica™ CH Analyzer, Such measurements are used in the diagnosis and treatment of renal diseases, and in monitoring renal dialysis.

The Atellica™ CH Chemistry Calibrator (CHEM CAL) is for in vitro diagnostic use in calibrating the Crea 2 assay using the Atellica™ CH Analyzer.

The Atellica CH Creatinine_2 (Crea_2) assay is based on the reaction of picric acid with creatinine in an alkaline medium as described in the original procedure of Jaffe. Creatinine reacts with picric acid in an alkaline medium to produce a red-colored creatinine-picrate complex. The rate of complex formation is measured at 505/571 nm and is proportional to the creatinine concentration. The Atellica CH Creatinine 2 (Crea_2) assay is a modification of the Jaffe method using rate blanking and intercept correction. Rate blanking is used to minimize bilirubin interference. Also, because nonspecific serum/plasma protein interactions with this reagent have been found to produce a positive bias of approximately 0.3 mg/dL (26.5 umol/L), serum/plasma measurements are automatically corrected by subtracting 0.3 mg/dL (26.5 umol/L) from each result.

The Atellica CH Chemistry Calibrator (CHEM CAL) is a 1 level lyophilized calibrator product prepared from bovine serum base product.

Here's an analysis of the provided text to extract the acceptance criteria and study details for the Atellica CH Creatinine 2 (Crea 2) and Atellica CH Chemistry Calibrator (CHEM CAL) devices:

1. Table of Acceptance Criteria and Reported Device Performance

Detailed Precision Results:

2. Sample Size Used for the Test Set and Data Provenance

• Detection Limit (LoB/LoD):
  • LoB: 4 samples with no analyte, tested 5 times a day for 3 days (60 reps total).
  • LoD: 4 low analyte samples, tested 5 times a day for 3 days (60 reps total).
• Limit of Quantitation (LoQ):
  • Serum: 10 low samples, 5 replicates each, on 3 reagent lots for 3 days, 5 calibrations per day (75 measurements per reagent lot per sample). Total of 2250 determinations.
  • Urine: Similar setup for urine samples. Total of 2250 determinations.
• Linearity Study:
  • Serum/Plasma: 12 samples (high and low concentration mixes). 5 replicates measured for each sample.
  • Urine: 10 samples (high and low concentration mixes). 5 replicates measured for each sample.
• Precision Studies:
  • Controls, serum, and plasma pools: 80 replicates (n=2 replicates, 2 times a day for at least 20 days).
• Interferences:
  • "Fresh sample pools" containing low or high levels of creatinine in serum and urine. Specific count not given, but refers to testing across these pools.
• Method Comparison (Predicate):
  • Serum: 140 remnant de-identified samples.
  • Urine: 109 remnant de-identified samples.
  • Data Provenance: "Remnant de-identified samples" implies retrospective patient data. "No patient history information was obtained." The studies were conducted internally by Siemens Healthcare Diagnostic Inc. R&D personnel.
• Method Comparison (IDMS):
  • Serum: 49 samples.
• Matrix Equivalency:
  • 58 matched serum and lithium heparin plasma samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of device (Creatinine assay system) does not typically involve human expert adjudication for its ground truth. The "ground truth" for a chemical assay is established through highly accurate reference methods or certified reference materials.

• Ground Truth for Method Comparison: The predicate device, ADVIA Chemistry Enzymatic Creatinine_2 (ECRE_2), served as the comparative "ground truth" for the method comparison study. Additionally, "Isotope Dilution Mass Spectrometry (IDMS)" was used as a reference method for a subset of samples, which is a highly accurate and precise method for determining analyte concentrations and is recognized as a gold standard in clinical chemistry.
• Ground Truth for Calibration/Standardization: The device uses "IDMS Reference Method" for standardization, and the predicate uses "SRM967" (Standard Reference Material 967, which is a NIST standard for creatinine in human serum, often value-assigned by IDMS). These are highly precise and accurate methods, not typically involving human expert consensus in the same way an imaging device would.

4. Adjudication Method for the Test Set

Not applicable for this type of in-vitro diagnostic device. Ground truth is established by quantitative measurement or comparison to a reference method, not by expert adjudication of human interpretations.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an in-vitro diagnostic device for quantitative chemical analysis, not an AI-assisted diagnostic imaging or interpretation device that would involve human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a standalone, automated analytical system (Atellica CH Analyzer) that performs the creatinine assay. The performance results reported (LoB, LoD, LoQ, Linearity, Precision, Interference, Method Comparison) represent the standalone performance of the assay on the analyzer. There is no human-in-the-loop component for the measurement of creatinine by this system.

7. The Type of Ground Truth Used

• Reference Methods:
  • The predicate device (ADVIA Chemistry Enzymatic Creatinine_2) was used as a reference for method comparison.
  • Isotope Dilution Mass Spectrometry (IDMS) was used as a highly accurate reference method for a subset of serum samples. This is considered a gold standard for creatinine measurement.
• Reference Materials: Standardization mentions "IDMS Reference Method," which implies traceability to primary reference materials. The predicate mentions SRM967, a certified reference material.
• Defined Protocols: CLSI (Clinical and Laboratory Standards Institute) protocols (EP17-A2, EP05-A3, EP06-A, EP7-A2, EP09-A3, EP28-A3c) were followed for various performance evaluations, which define how to establish performance characteristics against expected statistical and analytical metrics.

8. The Sample Size for the Training Set

Not explicitly mentioned in the provided text as a "training set" in the context of machine learning, which is typically what this question implies. For an IVD assay, method development and initial optimization would involve numerous experiments and samples, but these are typically not referred to as a "training set" in the AI sense. The text focuses on the validation studies performed to demonstrate performance.

9. How the Ground Truth for the Training Set Was Established

As above, the concept of a "training set" with established ground truth as used in AI/ML is not directly applicable here. The development of an IVD assay involves extensive R&D, where analytical methods are refined to accurately measure the analyte. The "ground truth" during this development phase would be established by reference methods or gravimetric/volumetric preparations of known concentrations, similar to how the validation ground truth is established.

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MEDICA's EasyQC - Chemistry, Levels A and B, is a quality control material for clinical chemistry intended for use in the MEDICA EasyRA Chemistry Analyzer to estimate test precision and to detect any potential systemic analytical deviations.

MEDICA's EasyElectroLytes kit is a quality control material for clinical chemistry intended for use in the MEDICA EasyRA Chemistry Analyzer to estimate test precision and to detect any potential systemic analytical deviations.

MEDICA's EasyQC - Chemistry and Electrolytes, Levels A and B is a quality control material for clinical chemistry intended for use in the MEDICA EasyRA Chemistry Analyzer to estimate test precision and to detect any potential systemic analytical deviations.

MEDICA's EasyCal - Multiconstituent Calibrator is intended for use in the MEDICA EasyRA Chemistry Analyzer to establish points of reference in the measurement of a number of analytes in human serum.

MEDICA CREA-U Cal is intended for use in the MEDICA EasyRA Chemistry Analyzer to establish points of reference in the measurement of Creatinine in urine.

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The provided text is a 510(k) premarket notification approval by the FDA for Medica Corporation's quality control materials and calibrators for clinical chemistry. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of AI/ML or diagnostic performance. Instead, it confirms that the devices are substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the given text. The document focuses on regulatory approval rather than a detailed technical performance study with acceptance criteria.

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The Chemistry calibrator is for use as a calibrator of Pointe Scientific, Inc. clinical chemistry assays. The analyte constituents, set-point values and instruments are provided in the product labeling.

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The provided text is a 510(k) premarket notification letter from the FDA regarding a Multi-Analyze Chemistry Calibrator. This document approves the device based on its substantial equivalence to a legally marketed predicate device.

It is crucial to understand that this document does not contain information about the performance or acceptance criteria of a diagnostic imaging AI device. Instead, it concerns an in-vitro diagnostic (IVD) calibrator product. Therefore, the details requested in the prompt, such as "test set," "ground truth," "MRMC study," "human readers improve with AI," and "standalone algorithm performance," are not applicable to the content provided.

The document discusses regulatory approval for a calibrator, not a device that analyzes images or medical data for diagnosis using AI.

As such, I cannot extract the requested information as it is not present in the provided text.

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The Olympus Lyophilized Chemistry Calibrator is a two level general purpose chemistry calibrator designed to provide suitable calibration levels for OLYMPUS analyzers employing the OLYMPUS Methodologies.

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This is an FDA 510(k) clearance letter for a calibrator device, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, and ground truth for an AI/ML device is not applicable and cannot be extracted from the provided text.

The document discusses the substantial equivalence of the "Olympus Lyophilized Chemistry Calibrator" to a legally marketed predicate device. It confirms the device's classification and allows it to proceed to market. The "Indications for Use Statement" clarifies that it's a two-level general-purpose chemistry calibrator for Olympus analyzers using Olympus methodologies.

In summary, none of the requested information regarding AI/ML device performance or studies is present in this 510(k) document.

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For in vitro diagnostic use in the calibration of the ADVIA 1650 Chemistry system for certain chemistry methods.

The Bayer Special Chemistry Calibrators are for one absolute value of calibrator material prepared in human serum with nonserum constituents added. All the analytes currently in the calibrator material are: Acid Phosphatase Lactate Lipase Direct TIBC. The intention of this submission is to add the assigned values to the labeling claims for: Direct TIBC. As with the predicate device, the calibrator materials are lyophilized and require reconstitution with 5.0 mL distilled water. These calibrators are only for use on the Bayer ADVIA 1650 Chemistry Analyzer.

The provided text describes a submission for a Special Chemistry Calibrator from Bayer Healthcare LLC. It focuses on regulatory approval (510(k)) and states that the device is substantially equivalent to a previously cleared predicate device. The key difference in this submission is the addition of assigned values for "Direct TIBC" to the labeling claims.

However, the document does not contain the detailed acceptance criteria or a study proving the device meets those criteria, as typically requested in your prompt. The document is a regulatory submission for premarket notification, establishing substantial equivalence based on the device's similarity to an existing one, rather than presenting a detailed performance study with acceptance criteria.

Therefore, I cannot provide the requested information. The document explicitly states:

• No acceptance criteria: The document does not define specific performance metrics or acceptance criteria for the "Direct TIBC" calibration.
• No study proving acceptance criteria: Since no acceptance criteria are given, there is no study described that proves the device meets them. The basis for approval is substantial equivalence to a predicate device.
• No sample sizes, data provenance, expert details, adjudication methods, MRMC studies, or standalone performance details: These are all elements of a detailed performance study, which is not present in this 510(k) summary. The nature of the submission focuses on demonstrating equivalence, not on extensive de novo performance testing against new criteria.
• Type of ground truth, training set size, and ground truth establishment for the training set: These details are also absent as no new substantial performance study is being presented. The device is a calibrator, and its "ground truth" would be related to its assigned values and stability, which are stated to be similar to the predicate device.

The main points from the document pertinent to its "performance" (as understood in a regulatory context for this type of device) are:

• Device Name: Special Chemistry Calibrator
• Proprietary/Trade Name: Bayer ADVIA 1650 Special Chemistry Calibrator
• Intended Use: Calibrators for in vitro diagnostic use to monitor the precision and accuracy of certain chemistry test procedures for the ADVIA 1650 Chemistry analyzer.
• Key Change: Addition of assigned values to the labeling claims for "Direct TIBC".
• Substantial Equivalence: The device is stated to be "identical in intended use, storage and handling, stability, source material (human serum), and instructions for use as the previously cleared Special Chemistry Calibrators." The only difference is the added analyte value for Direct TIBC.

Due to the nature of the provided text, which is a 510(k) summary focused on substantial equivalence rather than a detailed performance study, I cannot extract the specific information requested in your prompt regarding acceptance criteria and a proving study.

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For in vitro diagnostic use in the calibration of the ADVIA 1650 Chemistry system for certain chemistry methods.

The Bayer Special Chemistry Calibrator are for one absolute value of calibrator material prepared in human serum with nonserum constituents added.

All the analytes currently in the calibrator material are: Acid Phosphatase Lactate Pancreatic Amylase Lipase

The intention of this submission is to add the assigned values to the labeling claims for: Pancreatic Amylase Lipase

The provided text describes a 510(k) submission for a Special Chemistry Calibrator and does not contain information about acceptance criteria or a study proving device performance in the context of AI, imaging, or statistical metrics like sensitivity, specificity, or AUC. The document focuses on the regulatory submission for an in vitro diagnostic device and its substantial equivalence to a predicate device.

Therefore, I cannot fulfill the request to provide acceptance criteria or a study description as the necessary information is not present in the given text.

Here's why:

• The device is a "Special Chemistry Calibrator," which is a material used to calibrate laboratory instruments. It is not an AI/ML device, an imaging device, or one that would typically have performance evaluated with metrics like those requested (e.g., sensitivity, specificity, AUC).
• The document's purpose is a 510(k) summary, which establishes substantial equivalence to a predicate device based on intended use, material composition, and performance on a specific analytical system. It doesn't typically detail exhaustive performance studies with statistical thresholds for AI or imaging.
• The "Substantial Equivalence" section explicitly states, "The Special Chemistry Calibrators are identical in intended use, storage and handling, stability, source material (human serum), and instructions for use as the previously cleared Special Chemistry Calibrator." The only difference is adding assigned values for two new analytes. This suggests that extensive new performance studies (especially for AI or imaging) would not be required or detailed in this type of submission.

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Bayer SETpoint Calibrator is intended for in vitro diagnostic use to calibrate the following systems: Technicon RA and opeRA Chemistry Systems, Technicon RA-100, Technicon DAX, ADVIA 1650/ADVIA 2400 Chemistry systems, and ADVIA IMS Chemistry systems.

The SETpoint Chemistry Calibrator is a bovine serum based solution containing various nonhuman constituents at defined concentrations.

The provided text describes the Bayer Healthcare SETpoint Chemistry Calibrator. It is a calibrator for multiple analytes intended for in vitro diagnostic use to calibrate various Technicon and ADVIA Chemistry systems.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define "acceptance criteria" in a quantitative manner (e.g., specific thresholds for performance metrics). Instead, it states that the device's performance is "similar to other products in commercial distribution intended for similar use" and validates stability according to Bayer procedures. The primary performance characteristic discussed is stability.

2. Sample Size Used for the Test Set and Data Provenance

The document states, "The stability of the SETpoint calibrator values has been validated according to Bayer procedures and is based on the results of three separate lots of calibrator material."

• Sample Size for Test Set: Three separate lots of calibrator material.
• Data Provenance: Not explicitly stated, but assumed to be internal testing conducted by Bayer Healthcare Diagnostics Division. The data is prospective, as it involves the testing of the newly developed lots.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is typically not applicable to calibrator performance studies. The "ground truth" for a calibrator's performance lies in its ability to consistently produce accurate and stable values for the analytes it is designed to measure. This is assessed through analytical methods and comparisons to established reference standards, not through consensus of human experts.

4. Adjudication Method for the Test Set

Not applicable. Statistical or analytical methods are used to determine stability and performance, not human adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a calibrator device, not an AI-powered diagnostic tool that involves human readers interpreting cases.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not directly applicable in the terms of an "algorithm only" study, as this is a physical calibrator product. However, the stability validation of the calibrator itself can be considered a standalone performance assessment. The document states: "The stability of the SETpoint calibrator values has been validated according to Bayer procedures..." This indicates that the performance of the calibrator material itself was evaluated independently to ensure it met internal specifications for stability.

7. The Type of Ground Truth Used

The ground truth for the performance of a chemical calibrator is established by:

• Reference Standards: The manufacturer uses highly accurate reference methods and/or certified reference materials to assign target values to the analytes within the calibrator.
• Analytical Methods: The stability and accuracy of the calibrator's assigned values are verified through a series of analytical tests over time and under various conditions to ensure they remain within acceptable specifications.

In this document, the "ground truth" for stability is established by Bayer's internal procedures and validated against those procedures, which would involve comparison to expected values or reference standards for the analytes.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set. The "training" for a calibrator happens during its manufacturing process to ensure proper formulation and assigned values, rather than through data input.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set in the context of an AI algorithm. The quality and "ground truth" of a calibrator are established through manufacturing, quality control, and testing against recognized analytical standards, as mentioned in point 7.

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Intended for the calibration of multiple in vitro quantitative chemistry assays on automated chemistry analyzers, such as the Roche Cobas Mira Chemistry Analyzers. "A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens."

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The provided text is a 510(k) premarket notification letter from the FDA regarding a JAS Chemistry Calibrator. This device is a calibrator intended for use in calibrating multiple in vitro quantitative chemistry assays on automated chemistry analyzers.

Based on the information provided, this document addresses a diagnostic device that performs calibration, not an AI/ML-driven device or study evaluating human reader performance. Therefore, most of the requested information (acceptance criteria, device performance metrics, study design elements for AI/ML, human reader studies, etc.) is not applicable or extractable from this regulatory document.

However, I can extract information related to the device type and its intended use.

1. A table of acceptance criteria and the reported device performance

• This document does not contain any acceptance criteria or reported device performance data. It is a regulatory clearance letter, not a performance study report. For a calibrator, acceptance criteria would typically involve accuracy, precision, linearity, and stability, but these are not present here.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. This document does not describe a clinical study or a test set as defined for AI/ML performance evaluation. Calibrator performance is typically evaluated by methods like linearity, recovery studies, and value assignment, not through test sets with human specimens in the context of diagnostic accuracy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. Ground truth in the context of calibrators refers to the accurately assigned values for the analytes within the calibrator, which are established through certified reference materials and rigorous analytical methods, not typically by expert consensus in the diagnostic sense implied by the question.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This device is a chemical calibrator, not an AI/ML diagnostic algorithm that would be used by human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical chemical calibrator, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For a chemical calibrator, the "ground truth" for its assigned values would be established through traceability to internationally recognized reference materials and/or methods, often involving multiple reference laboratories and certified analytical techniques. This is a metrological concept, distinct from clinical ground truth like pathology or expert consensus. The document does not specify how the values for this particular calibrator were established.

8. The sample size for the training set

• Not applicable. There is no "training set" for a chemical calibrator in the sense of AI/ML.

9. How the ground truth for the training set was established

• Not applicable.

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